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A Study of Bitopertin (RO4917838) in Healthy Male Volunteers

NCT01636492 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 71

Last updated 2016-11-02

No results posted yet for this study

Summary

This randomized, double-blind, placebo-controlled, dose-escalating study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of bitopertin in healthy male volunteers. Subjects will be randomized in cohorts to receive single oral doses of either bitopertin or placebo.

Conditions

  • Healthy Volunteer

Interventions

DRUG

bitopertin

Single oral dose

DRUG

placebo

Single oral dose

Sponsors & Collaborators

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Study Design

Allocation
RANDOMIZED
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2005-11-30
Primary Completion
2006-08-31
Completion
2006-08-31

Countries

  • New Zealand

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01636492 on ClinicalTrials.gov